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OpenTrials
Completed

NCT Number: NCT03719157

Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy

Main purpose of this prospective single center randomized study is to compare the analgesic effect of ultrasound guided Unilateral Oblique Subcostal Transversus Abdominis Plane (TAP),unilateral Erector Spinae Plane (ESP) blocks and Port site infiltration of local anesthetic in subjects undergoing laparoscopic cholecystectomy. Total 100 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent laparoscopic cholecystectomy will recruit to the study.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Regional Anesthesia Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diskapi education and research hospital

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA Status 1-2 patients Exclusion criteria
  • Patients with a body mass index (BMI) of >40kg/m2
  • ASA score of >III
  • Previous abdominal surgery
  • Pregnant or breastfeeding patients
  • Patients with coagulopathy
  • Known local anesthetic allergy
  • infection at the injection site

Treatment and study plan

Unilateral ESP Block

Procedure

USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture

Unilateral OSTAP Block

Procedure

USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture

Injection of Local Anesthetic to Trocar Insertion

Procedure

Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.

Intravenous patient controlled analgesia

Drug

All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: 24 hours

    Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours.

  2. Postoperative pain scores: NRS

    Time frame: 24 hours

    Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours.

Secondary outcomes

  1. postoperative nause and vomiting

    Time frame: 24 hours

    The patient with nausea and vomiting will be recorded.

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2018
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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